A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
A Randomized Study of the Clinical Effects of Initiating or Changing Antiretroviral Therapy Based on Plasma HIV RNA Quantitation Compared With Initiating or Changing Therapy Based on Current Clinical Practice Alone
PRIMARY: To compare the clinical efficacy of two decision making strategies for initiating or changing antiretroviral therapy: decision making based on current clinical practice alone (i.e., initiating or changing therapy based on CD4 count decline and/or clinical progression) versus decision making based on plasma HIV RNA quantitation in addition to current clinical practice.
SECONDARY: To evaluate toxicity, biological markers, and patient management in the two arms.
Although changing therapies is a common strategy in the treatment of HIV disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms.
研究概览
地位
条件
详细说明
Although changing therapies is a common strategy in the treatment of HIV disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms.
Patients are randomized to a decision making strategy for initiating or changing therapy based on current clinical practice alone vs. decision making based on plasma HIV RNA quantitation in addition to current clinical practice in patients with <= 300 CD4+ cells/mm3. All patients in the RNA arm as well as a subset (n = 183) of those in the CCP arm will have a plasma HIV RNA quantitation drawn every 4 months. The results of these quantitations will be blinded until the end of the study. CD4 counts will be obtained at least every 4 months if the previous count was > 20 cells/mm3. The remaining patients in the CCP arm will have CD4 counts obtained according to their clinicians' current clinical practices. Medications, clinical status, and changes in antiretroviral therapy will be recorded for all patients in the study. Patients are stratified by CD4+ cell count (<100 cells/mm3 [200 patients] vs. 100-300 cells/mm3 [900 patients]).
研究类型
注册
联系人和位置
学习地点
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California
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San Francisco、California、美国、94110
- Community Consortium of San Francisco
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Colorado
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Denver、Colorado、美国、802044507
- Denver CPCRA / Denver Public Hlth
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District of Columbia
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Washington、District of Columbia、美国、20422
- Veterans Administration Med Ctr / Regional AIDS Program
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Georgia
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Atlanta、Georgia、美国、30308
- AIDS Research Consortium of Atlanta
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Illinois
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Chicago、Illinois、美国、60657
- AIDS Research Alliance - Chicago
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Louisiana
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New Orleans、Louisiana、美国、70112
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
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Maryland
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Baltimore、Maryland、美国、21201
- Baltimore Trials
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Michigan
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Detroit、Michigan、美国、48202
- Henry Ford Hosp
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Detroit、Michigan、美国、48201
- Comprehensive AIDS Alliance of Detroit
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New Jersey
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Camden、New Jersey、美国、08103
- Southern New Jersey AIDS Cln Trials / Dept of Med
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Newark、New Jersey、美国、071032842
- North Jersey Community Research Initiative
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New Mexico
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Albuquerque、New Mexico、美国、871315271
- Partners Research
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New York
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New York、New York、美国、10037
- Harlem AIDS Treatment Group / Harlem Hosp Ctr
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Oregon
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Portland、Oregon、美国、97210
- The Research and Education Group
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Portland、Oregon、美国、972109951
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Philadelphia FIGHT
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Virginia
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Richmond、Virginia、美国、23298
- Richmond AIDS Consortium
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
Patients must have:
- HIV infection.
- CD4 count <= 300 cells/mm3.
- NO stage 2 or worse AIDS dementia complex.
- Life expectancy of at least 6 months.
- Reasonably good health.
- age >= 13yrs.
- signed informed consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Disorders or conditions that may prevent adequate compliance with study requirements.
Patients with the following prior conditions are excluded:
- Stage 2 >= AIDS dementia complex.
学习计划
研究是如何设计的?
设计细节
合作者和调查者
调查人员
- 学习椅:Perez G
- 学习椅:Thompson M
出版物和有用的链接
一般刊物
- Doepel LK. Volunteers needed for study of HIV viral load test. NIAID AIDS Agenda. 1995 Dec:3.
- James JS. Viral load: new "strategy" trial in 15 U.S. cities. AIDS Treat News. 1995 Oct 20;(no 233):1-3.
- Raghavan S, Grant LB, Barisch G, Thompson M, Williams B, Matoe N, el-Sadr WM. Change in log10 HIV RNA and protease inhibitor use associated with weight change in HIV+ men in a national clinical trial. Int Conf AIDS. 1998;12:556 (abstract no 32180)
研究记录日期
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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